Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01805921
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2013-03-05
Brief Title:
RSV001 - A New Vaccine to Prevent Severe Viral Chest Infections
Sponsor:
ReiThera Srl
Organization:
ReiThera Srl
Study Overview
Official Title:
A Phase I Study to Assess Safety and Immunogenicity of a New Respiratory Syncytial Virus RSV Vaccine Based on the RSV Viral Proteins F N and M2-1 Encoded by Simian Adenovirus PanAd3-RSV and Modified Vaccinia Virus Ankara MVA-RSV
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study we are testing a new vaccine against Respiratory Syncytial Virus RSV
This virus can cause respiratory infections such as bronchiolitis and pneumonia It affects all ages but especially infants adults with a suppressed immune system and the elderly RSV only infects humans and occurs in epidemics each winter It is the single most common cause of severe respiratory illness in children
There is no effective anti-viral medication to treat RSV infections There is a monoclonal antibody which can be given to at-risk children given by injection on a monthly basis during winter to provide short term protection against infection but it is only partially effective and prohibitively expensive Currently there is no licensed vaccine to prevent RSV infection and there remains a real need to develop a vaccine as a cost-effective method to save lives and reduce the cost of disease caused by RSV
This virus can cause respiratory infections such as bronchiolitis and pneumonia It affects all ages but especially infants adults with a suppressed immune system and the elderly RSV only infects humans and occurs in epidemics each winter It is the single most common cause of severe respiratory illness in children
There is no effective anti-viral medication to treat RSV infections There is a monoclonal antibody which can be given to at-risk children given by injection on a monthly basis during winter to provide short term protection against infection but it is only partially effective and prohibitively expensive Currently there is no licensed vaccine to prevent RSV infection and there remains a real need to develop a vaccine as a cost-effective method to save lives and reduce the cost of disease caused by RSV
Detailed Description:
We are testing two new RSV vaccines given in different combinations and by different routes of administration Each vaccine uses the same RSV proteins to stimulate immune responses These proteins are the F Fusion N Nucleocapsid and M2-1 Matrix proteins The F protein sits on the surface of the virus and is needed to infect human cells Antibodies to this protein are an important mechanism to prevent infection The N and M2-1 proteins are needed for viral replication and are targets of immune recognition
The two vaccines in this study contain all three of these proteins However they are delivered into the body using different vectors which are harmless carrier viruses In this study we have employed two different vectorsa simian adenoviruses PanAd3 and Modified Vaccinia virus Ankara MVA
We administer these vaccines using a prime-boost strategy in which one of these vaccines is used to prime the immune system which is then boosted 4 or 8 weeks later depending on the groups by administration of an alternative vaccine or the same vaccine given by a different route
The two vaccines in this study contain all three of these proteins However they are delivered into the body using different vectors which are harmless carrier viruses In this study we have employed two different vectorsa simian adenoviruses PanAd3 and Modified Vaccinia virus Ankara MVA
We administer these vaccines using a prime-boost strategy in which one of these vaccines is used to prime the immune system which is then boosted 4 or 8 weeks later depending on the groups by administration of an alternative vaccine or the same vaccine given by a different route
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-003589-34 | EUDRACT_NUMBER | None | None |